MedTech Conference 2022: Meeting the Multiple Challenges of Ensuring a Resilient Health Care Supply Chain
Maureen Mulvihill, President and CEO, will be speaking at the 2022 MedTech Conference along with Dan Carestio, Jonathan Rennert, and Monish Rajpal. The medtech industry, which includes competitors within the health care supply chain, continues to innovate and meet unmet health care needs on a global basis. COVID-19 and its impact has underscored the importance of supply chain resilience to deliver on clinical priorities. Similarly, in an age of digitalization, consolidation and increased focus on care outside of hospitals, there are additional complexities intensifying pressure on the supply chain. This session will explore supply chain executives’ real-world experiences managing multiple, concurrent supply chain challenges and look at how they were able to achieve their strategic goals while improving their operational systems for future resilience.
MedTech Conference 2022: Embracing the Revolution- Regulatory and Technology Challenges and Opportunities Presented by 3D Printing for Medical Devices
Douglas Dillon, Director QA/RA will also be speaking at the 2022 MedTech Conference alongside Jamie Wolszon, Anna D’Lima, Lauralyn McDaniel, and Len Morrissey. Additive Manufacturing (3D printing) has moved from being used only for prototyping and fixturing to producing end use medical products in the last few years. With the speed at which advancements are taking place in this field, from the printer technologies to accessories to materials developments, this transition is expected to not only continue, but to accelerate in the coming years. This discussion will cover interesting uses of new technology for medical devices by traditional manufacturers of all sizes. Additionally, unique considerations for submissions of 3D printed devices, including specific challenges for small companies, will be addressed. The panel will discuss the emerging hot topic of appropriate FDA regulation of point of care device manufacturing.
Bringing motion to medicine: How Actuated Medical is innovating deep brain stimulation and more
Actuated Medical is making electrode placement for deep brain stimulation easier and less traumatic.
Nearly 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more.
“I was actually sitting in a doctor’s office and I was showing him the little actuators. He’s like, ‘Maureen, I don’t need that. I need the whole system FDA approved,’” she told Medical Design & Outsourcing.
Actuated Medical's President and CEO Awarded International Chief Science Officer (CSO) Mentor of the Year
Maureen L. Mulvihill, Ph.D., was awarded the 2022 International Chief Science Officer (CSO) Mentor of the Year at the June CSO Saturday Meeting. The meeting involved Science, Technology, Engineering and Math (STEM) students from Arizona, Georgia, Oregon, Kenya, the Philippines, and Mexico. CSO Mentors are community leaders and professionals who serve as role models for students in grades 6-12 that want to pursue STEM careers. Over the past two years, Maureen has been involved with the ENGINE of Central PA CSO program. Last year, Maureen participated as a STEM panelist during the CSO’s Leadership Training Institute. This year, Maureen opened Actuated’s doors to several high school students for a CSO Shadow Day opportunity to learn about engineering careers and presented to CSOs across the world during a medical technology themed CSO Saturday event.
“The CSO program gives students the opportunity to learn about STEM related fields and to build leadership skills by developing STEM programs in their communities. The CSO student have such positive energy and are so eager to learn. I am very honored to receive the 2022 International Chief Science Officer (CSO) Mentor of the Year award,” said Maureen L. Mulvihill, President and CEO, Actuated Medical.
SAGES 2022 Next Big Thing Session Podium Presentation
Dr. Eric M. Pauli and coauthors Joshua S. Winder, MD, and Vamsi V. Alli, MD from the Pennsylvania State University College of Medicine will be presenting at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual Meeting March 18 in the Next Big Thing Session. Their presentation entitled “Novel Accessory Designed to Facilitate Complex Mucosal Resection” describes a safety study performed with Actuated Medical’s GripTract-GI endoscopic tissue manipulator.
“Dr. Pauli is a leading champion for our GripTract-GI device. The study shows the potential for GripTract to improve procedure outcomes and improve clinician learning curves. GripTract, while still in development, may lead to more USA clinicians being trained in endoscopic submucosal dissection (ESD), thus expanding that market in the USA,” said Maureen L. Mulvihill, Ph.D., President and CEO of Actuated Medical... Click to continue reading…
Actuated Medical Offering Specialized Product Development for MedTech Innovators
Actuated Medical specializes in taking medical devices from concept to market ready product – from start to finish. They have deep expertise in tissue dynamics and penetration, acoustic engineering, electronics and software development, and 3D printing. They focus exclusively on development of medical devices and are currently helping other Innovators solve design and regulatory challenges. Actuated’s facility doubled in 2021 and has increased its capacity to conduct contract product development and manufacturing including customer equipment placement.
“Our exceptionally skilled team includes electrical, mechanical, and biomedical engineers with expertise in medical device commercialization. We are currently helping several innovators solve engineering problems. With our expansion, we have the capacity to help others,” said Maureen L. Mulvihill, President and CEO of Actuated Medical.
Actuated Medical Appointed Frederick A. Browne M.D. as Chief Medical Officer
Actuated Medical appointed Frederick A. Browne, M.D. as Chief Medical Officer. Dr. Browne brings a unique perspective on clinical and healthcare administration to the team. He continues to serve as VP and CMO of Griffin Hospital in Derby, CT, and as Adjunct Professor in the newly accredited Master of Physician Assistant Studies program at Sacred Heart University in Stamford, CT.
“Dr. Browne’s expertise in population health, hospital administration and clinical needs is helping Actuated purposefully bring our innovative medical devices to patients.”, said Maureen L. Mulvihill, President and CEO of Actuated Medical. Click to continue reading…
Actuated Medical Awarded SBIR Fast Track for Additive Manufacturing of Patient-Specific Masks and Nasal Prongs
Actuated Medical, Inc. has been awarded a Small Business Innovative Research (SBIR) Fast Track grant from the National Institutes of Health (NIH) / National Institute of Child Health and Human Development for its “Additive Manufacturing of Patient-Specific Masks and Nasal Prongs to Improve Pediatric Ventilation Outcomes and Reduce Pressure Sores.” Click to continue reading…
Maureen L. Mulvihill, Ph.D. Appointed to the Life Sciences Pennsylvania Board of Directors
Maureen L. Mulvihill, Ph.D., the Life Sciences Pennsylvania 2020 Frank Baldino Bioscience CEO of the Year, was recently appointed to the Life Sciences Pennsylvania Board of Directors. As a LSPA BOD member, she gives a voice and advocates for Pennsylvanian entrepreneurial and startup life science companies. Click to continue reading…
Actuated Medical Offers Employees Paid Time Off for Second Covid-19 Vaccination
Maureen L. Mulvihill, PhD, president and CEO of Actuated Medical, Inc., recently announced the company’s decision to offer employees paid time off equivalent to one day of work for all employees who receive their second dose of a Covid-19 vaccine. Click to continue reading…
Actuated Medical Receives SBA's Prestigious Tibbetts Award
The U.S. Small Business Administration (SBA) selected Actuated Medical as a 2020 Tibbetts Award Winner. The SBA presents these national awards to companies who exemplify the very best of the Small Business Innovation Research (SBIR) program. Click to continue reading…
TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model
Actuated Medical, Inc. (AMI) recently received its sixth Food and Drug Administration (FDA) 510(k) clearance for the TubeClear® system. Clearance number K200646 introduces a Clearing Stem model that is compatible with select gastro-jejunostomy (GJ) feeding tubes. Click to continue reading…
Actuated Medical in other Publications
Actuated Medical is excited to be featured in the Women in Engineering Issue of Medical Design & Outsourcing, October 2022. Our CEO, Maureen Mulvihill, was featured in “10 women-led medtech startups you should know” on pages 38-41.
The Medical Design & Outsourcing editorial team drew on its resources to create this list of womenled startups. These companies are less than 10 years old or are still working toward commercialization of products and were founded by women and/or are led by women.
Nearly 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more.
“I was actually sitting in a doctor’s office and I was showing him the little actuators. He’s like, ‘Maureen, I don’t need that. I need the whole system FDA approved,’” she told Medical Design & Outsourcing.
Mulvihill understood that sentiment and went on to start Actuated Medical with the idea of putting motion into medicine.
I lead a small company that created a mechanical system to clear clogs in medical tubes, the TubeClear system. The first patient ever to use the product was a 27-year-old soldier in intensive care at Walter Reed hospital. The seed funding for my device development came from federal programs that some influential members of Congress could now limit or shut down. That would be a colossal mistake.
Congress created the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to encourage innovations from U.S. high technology startups like mine to meet government and industry needs. Participating agencies include the National Institutes of Health to support small companies to develop technologies to improve the health of U.S. patients.
Burn victims at the University of California, Davis. Critical care patients at Harborview Medical Center, Seattle. Critical care surgical patients at Ohio State University Wexner Medical Center. Veterans in Omaha. A device called the TubeClear system unclogs medical tubes in all those settings. The first patient ever to use the technology was a 27-year-old soldier in intensive care at Walter Reed hospital in Washington, D.C. TubeClear would not have been possible without earning highly competitive grant funding from the federal Small Business Innovation Research (SBIR) program, said Maureen L. Mulvihill, PhD, president, chief executive officer, and co-founder of maker Actuated Medical. The central Pennsylvania firm applies electronically controlled motion to medical devices to improve patient outcomes. With 22 employees, the federally certified women-owned business is a member of AdvaMed Accel for start-up companies.
An article published by Bloomberg in July focused on the accelerating reshoring trend in manufacturing and noted that companies aren’t just talking about reshoring — they’re taking action.
Chip shortage may continue to be a manufacturing challenge
Mulvihill noted that “even with the significant government support, it will take many years for these chip manufacturers to begin producing products that industry needs today. We will still have supply chain issues while companies scale up production in the United States.”
